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| 申请号 | 产品号 | 商品名 | 活性成分 | 活性成分 | 剂型/给药途径 | 规格/剂量 | 申请机构 | 批准时间 | 参比制剂 | 标准制剂 | 市场状态 | TE |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| (ANDA) 219883 | 004 | ROPIVACAINE HYDROCHLORIDE | ROPIVACAINE HYDROCHLORIDE | 盐酸罗哌卡因 | SOLUTION;INJECTION | 20MG/10ML (2MG/ML) | NEOCUBES PHARMA | 2025-10-08 | No | No | RX | AP |
| (ANDA) 219883 | 005 | ROPIVACAINE HYDROCHLORIDE | ROPIVACAINE HYDROCHLORIDE | 盐酸罗哌卡因 | SOLUTION;INJECTION | 100MG/20ML (5MG/ML) | NEOCUBES PHARMA | 2025-10-08 | No | No | RX | AP |
| (ANDA) 208557 | 002 | RIVAROXABAN | RIVAROXABAN | 利伐沙班 | TABLET;ORAL | 10MG | TARO | 2025-10-07 | No | No | RX | AB |
| (ANDA) 208557 | 004 | RIVAROXABAN | RIVAROXABAN | 利伐沙班 | TABLET;ORAL | 20MG | TARO | 2025-10-07 | No | No | RX | AB |
| (ANDA) 216097 | 004 | ISOTRETINOIN | ISOTRETINOIN | 异维A酸 | CAPSULE;ORAL | 30MG | AMNEAL PHARMS NY | 2025-10-07 | No | No | RX | AB2 |
| (ANDA) 216792 | 001 | FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE | FEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE | 盐酸非索非那定;盐酸伪麻黄碱 | TABLET, EXTENDED RELEASE;ORAL | 60MG;120MG | L PERRIGO CO | 2025-10-07 | No | No | OTC | |
| (ANDA) 219677 | 003 | LAMOTRIGINE | LAMOTRIGINE | 拉莫三嗪 | TABLET, ORALLY DISINTEGRATING;ORAL | 100MG | TARO | 2025-10-07 | No | No | RX | AB |
| (ANDA) 219677 | 004 | LAMOTRIGINE | LAMOTRIGINE | 拉莫三嗪 | TABLET, ORALLY DISINTEGRATING;ORAL | 200MG | TARO | 2025-10-07 | No | No | RX | AB |
| (ANDA) 216097 | 005 | ISOTRETINOIN | ISOTRETINOIN | 异维A酸 | CAPSULE;ORAL | 35MG | AMNEAL PHARMS NY | 2025-10-07 | No | No | RX | AB2 |
| (ANDA) 216097 | 001 | ISOTRETINOIN | ISOTRETINOIN | 异维A酸 | CAPSULE;ORAL | 10MG | AMNEAL PHARMS NY | 2025-10-07 | No | No | RX | AB2 |
| (ANDA) 208557 | 003 | RIVAROXABAN | RIVAROXABAN | 利伐沙班 | TABLET;ORAL | 15MG | TARO | 2025-10-07 | No | No | RX | AB |
| (ANDA) 216097 | 006 | ISOTRETINOIN | ISOTRETINOIN | 异维A酸 | CAPSULE;ORAL | 40MG | AMNEAL PHARMS NY | 2025-10-07 | No | No | RX | AB2 |
| (ANDA) 219677 | 001 | LAMOTRIGINE | LAMOTRIGINE | 拉莫三嗪 | TABLET, ORALLY DISINTEGRATING;ORAL | 25MG | TARO | 2025-10-07 | No | No | RX | AB |
| (ANDA) 219677 | 002 | LAMOTRIGINE | LAMOTRIGINE | 拉莫三嗪 | TABLET, ORALLY DISINTEGRATING;ORAL | 50MG | TARO | 2025-10-07 | No | No | RX | AB |
| (ANDA) 216097 | 002 | ISOTRETINOIN | ISOTRETINOIN | 异维A酸 | CAPSULE;ORAL | 20MG | AMNEAL PHARMS NY | 2025-10-07 | No | No | RX | AB2 |
| (ANDA) 216097 | 003 | ISOTRETINOIN | ISOTRETINOIN | 异维A酸 | CAPSULE;ORAL | 25MG | AMNEAL PHARMS NY | 2025-10-07 | No | No | RX | AB2 |
| (ANDA) 075413 | 004 | BUSPIRONE HYDROCHLORIDE | BUSPIRONE HYDROCHLORIDE | 盐酸丁螺环酮 | TABLET;ORAL | 7.5MG | RISING | 2025-10-06 | No | No | RX | AB |
| (ANDA) 075413 | 005 | BUSPIRONE HYDROCHLORIDE | BUSPIRONE HYDROCHLORIDE | 盐酸丁螺环酮 | TABLET;ORAL | 30MG | RISING | 2025-10-06 | No | No | RX | AB |
| (ANDA) 216484 | 001 | LIDOCAINE | LIDOCAINE | 利多卡因 | PATCH;TOPICAL | 5% | ALKEM LABS LTD | 2025-10-06 | No | No | RX | AB |
| (ANDA) 209242 | 004 | OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE | AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL | 苯磺酸氨氯地平;氢氯噻嗪;奥美沙坦酯 | TABLET;ORAL | EQ 10MG BASE;12.5MG;40MG | HETERO LABS LTD V | 2025-10-06 | No | No | RX | AB |



